A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms (STERLING)

A Prospective, Multi-center, Single Arm Study to Obtain "Real World" Clinical Data and Characterize the Acute and Long-term Performance of the MICRUSFRAME and GALAXY Coils Including the PulseRider Aneurysm Neck Reconstruction Device for the Endovascular Treatment of Intracranial Aneurysms

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Study Overview

• Status: Recruiting
• Conditions: Aneurysms
• Intervention / Treatment: Device: MICRUSFRAME and GALAXY coils

Detailed Description

A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lillian Ma; Phone Number: 9494668021; Email: lma46@its.jnj.com

Study Locations

• Belgium
  • Kortrijk, Belgium
    • Recruiting
    • Az Groeninge
    • Principal Investigator: Olivier Francois, MD
• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Reade De Leacy, MD
  • Ohio
    • Toledo, Ohio, United States, 43604
      • Recruiting
      • Mercy Health St. Vincent Medical Center
      • Principal Investigator: Osama Zaidat, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is between 21 and 80 years of age
2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

1. Pre-planned staged procedure on unruptured aneurysm
2. More than one aneurysm requiring treatment during the course of study
3. Fusiform aneurysm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coils; MICRUSFRAME and GALAXY coils	Device: MICRUSFRAME and GALAXY coils; MICRUSFRAME and GALAXY Coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion Rate	Occlusion rate at 12 Months post procedure	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Packing Density	Packing density will be evaluated based on aneurysm volume and the coils used during the procedure.	From enrollment to end of treatment at 12 months
2. Complete occlusion rate	Complete occlusion rate at 12 month follow-up	12 month
3. Recanalization Rate	Recanalization Rate: Any worsening of occlusion grading at 12 Month follow-up	12 Months
4. Device related serious adverse events	Any device related serious adverse events will be reported through 12 month follow-up	12 Months
5. Retreatment Rate	Aneurysm re-treatment rates will be tracked and recorded during the 12 month follow-up	12 Months
6. Modified Rankin Score	Modified Rankin Score (Scale from 0-6) at 12 Months. 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	12 Months
7. Length of hospital stay	Hospital stay length will be recorded	From enrollment to 12 Months

Collaborators and Investigators

• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
• Investigators: Principal Investigator: Reade De Leacy, Mount Sinai Hospital, New York; Principal Investigator: Osama Zaidat, Mercy Health St. Vincent Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CNV_2017_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes